Study of a Single Dose of Meningococcal Polysaccharide Diphtheria Toxoid Conjugate Vaccine (SP284) in Japanese Subjects

This study has been completed.

Sponsor:

Sanofi Pasteur, a Sanofi Company

ClinicalTrials.gov Identifier:

NCT01519713

First Posted: January 27, 2012

Last Update Posted: May 28, 2013

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
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Number of Participants With Serum Bovine Albumin Baby Rabbit (SBA-BR) Titers of >=1:8 Following Vaccination With One Dose of Menactra® Vaccine [ Time Frame: 28 Days post-vaccination ]

Functional antibody activity against meningococcal serogroups A, C, Y and W-135 antigens were determined by using a serum bovine assay using a baby rabbit complement (SBA-BR).

Number of Participants With a 4-Fold Rise in Serum Bovine Albumin Baby Rabbit (SBA-BR) Titers on Day 28 From Day 0 Following Vaccination With One Dose of Menactra® Vaccine. [ Time Frame: 28 Days post-vaccination ]

Functional antibody activity against meningococcal serogroups A, C, Y and W-135 antigens were determined by using a serum bovine assay using a baby rabbit complement (SBA-BR).

Functional antibody activity against meningococcal serogroups A, C, Y and W-135 antigens were determined by using a serum bovine assay using a baby rabbit complement (SBA-BR).

Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reactions Following Vaccination With One Dose of Menactra® Vaccine [ Time Frame: Day 0 up to Day 28 post-vaccination ]

Study of a Single Dose of Meningococcal Polysaccharide Diphtheria Toxoid Conjugate Vaccine (SP284) in Japanese Subjects

Official Title ICMJE

Immunogenicity and Safety of a Single Dose of a Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine (SP284) in Japanese Subjects

Brief Summary

This study is designed to assess the safety and immunogenicity of a single dose of Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine (SP284) to support registration of the product in Japan.

Primary Objective:

To describe the seroprotection rate [% of subjects with serum bactericidal assay using baby rabbit complement (SBA-BR) ≥1:128] to meningococcal antigens (serogroups A, C, Y and W-135) following vaccination with SP284 vaccine in subjects 2 through 55 years of age

Secondary Objectives:

To describe the safety following receipt of SP284 vaccine in subjects 2 through 55 years of age

To describe the immune responses to meningococcal antigens (serogroups A, C, Y and W-135) following vaccination with SP284 vaccine in subjects 2 through 55 years of age.

Detailed Description

All participants will receive a single injection of Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate vaccine on Day 0 and undergo immunogenicity assessment and safety monitoring post-vaccination.

For subjects ≥ 20 years of age: Informed consent form has been signed and dated by the subjects. For subjects 2 to 19 years of age: Informed consent form has been signed and dated by the parent(s) or other legal representative. Also subjects 7 to 11 years of age will provide assent and subjects 12 to 19 years of age will provide written assent form.

Able to attend all scheduled visits and to comply with all trial procedures

For a woman of childbearing potential, use of an effective method of contraception or abstinence from at least 4 weeks prior to vaccination until at least 4 weeks after vaccination.

Exclusion Criteria:

Any acute and/or serious disease/illness that, in the opinion of the investigator, is at a stage where it might interfere with trial conduct or completion

History of meningococcal diseases, confirmed either clinically, serologically, or microbiologically

Known systemic hypersensitivity to any of the vaccine components, or history of a life threatening reaction to a vaccine containing the same substances of the study vaccine

Known or suspected congenital or current/ previous acquired immunodeficiency; or receipt of immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months; or long-term systemic corticosteroids therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months)

Participation in another clinical trial investigating a vaccine, drug, medical device, or medical procedure in the 4 weeks preceding the trial inclusion

Planned participation in another clinical trial during the present trial period

Receipt of blood or blood-derived products in the past 3 months, which might interfere with assessment of the immune response

Receipt of any vaccine within the four weeks preceding the trial vaccination, except for influenza vaccination, which may be received at least two weeks before the study vaccine

Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily

Current alcohol abuse or drug addiction that might interfere with the ability to comply with trial procedures

Identified as employee of the Investigator or study center, with direct involvement in the proposed study or other studies under the direction of that Investigator or study center, as well as family member (i.e., immediate, husband, wife and their children, adopted or natural) of the employees or the Investigator

Previous vaccination against meningococcal disease with either the trial vaccine or another vaccine

History of Guillain-Barré Syndrome.

Sex/Gender

Sexes Eligible for Study:

All

Ages

2 Years to 55 Years (Child, Adult)

Accepts Healthy Volunteers

Yes

Contacts ICMJE

Contact information is only displayed when the study is recruiting subjects